Lead Associate Principal Scientist, Drug-Device Testing

MSD; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

MSD is seeking an Associate Principal Scientist to lead end‑to‑end testing strategy for drug–device combination products within the DD&T organization. The role focuses on design verification while spanning method development, validation, and transfer across development to commercialization.

You will partner with cross‑functional teams and external partners to ensure strategies align with development, manufacturing, regulatory, and quality objectives, contributing to successful clinical

Qualifications

• B.S./M.S./Ph.D. in Mechanical Engineering with 3–8+ years of combination product development experience.
• Leadership in design verification programs with cross-disciplinary teams.
• Strong knowledge of device development, design controls, and regulatory expectations.

Responsibilities

• Lead design verification strategy for drug-device programs aimed at clinical and commercial approval.
• Define design inputs/outputs and lead verification plans and reports.
• Oversee external testing partners and risk communication to leadership.
• Author/ revise regulatory submissions (INDs, IMPDs, NDAs, BLAs).
• Collaborate with cross-functional teams to ensure readiness for clinical and commercial stages.

Skills

Design verification

Project leadership

Cross-functional collaboration

Regulatory knowledge

Mechanical testing

Analytical skills

Communication skills

Willing to travel

Education

B.S. Mechanical Engineering

M.S. Mechanical Engineering

Ph.D. Mechanical Engineering

Tools

SolidWorks

Instron

Zwick/Roell

XRCT

Optical microscopy

Job description

MSD is seeking an Associate Principal Scientist to lead end‑to‑end testing strategy for drug–device combination products within the DD&T organization. The role focuses on design verification while spanning method development, validation, and transfer across development to commercialization.

You will partner with cross‑functional teams and external partners to ensure strategies align with development, manufacturing, regulatory, and quality objectives, contributing to successful clinical